The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Belmont, Podiatry X-ray - Remex, Model Pd75.
Device ID | K870300 |
510k Number | K870300 |
Device Name: | BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 |
Classification | System, X-ray, Stationary |
Applicant | BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
Contact | John M Gardella |
Correspondent | John M Gardella BELMONT EQUIPMENT CORP. ONE BELMONT DR. Somerset, NJ 08873 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-28 |
Decision Date | 1987-03-25 |